Actively Recruiting
A Study of the Drug Letermovir as Prevention of Cytomegalovirus Infection After Stem Cell Transplant in Pediatric Patients
Led by Children's Oncology Group · Updated on 2026-05-05
105
Participants Needed
29
Research Sites
259 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This phase III single arm trial determines whether taking prophylactic letermovir will reduce the likelihood of infection with cytomegalovirus (CMV) in children and adolescents after stem cell transplant compared to estimated rate of infection without prophylaxis. The treatments used to prepare for HCT reduce the body's natural infection-fighting ability and increase the likelihood of an infection with a virus called cytomegalovirus. "Prophylaxis" means to take a drug to prevent a disease or side effect. Letermovir is an antiviral drug that stops cytomegalovirus from multiplying and may prevent cytomegalovirus infection and make the disease less severe.
CONDITIONS
Official Title
A Study of the Drug Letermovir as Prevention of Cytomegalovirus Infection After Stem Cell Transplant in Pediatric Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 2 to less than 18 years at enrollment
- Weight at least 6 kg
- Planned allogeneic hematopoietic cell transplant (bone marrow, peripheral blood stem cell, or cord blood)
- CMV sero-positive (positive CMV immunoglobulin G) or previously documented seropositive with hypogammaglobulinemia
- Feasibility of plasma CMV PCR testing within protocol timelines
- Performance status score (Lansky or Karnofsky) greater than 50
- Estimated glomerular filtration rate over 10 mL/min/1.73 m2 and not on dialysis
- Direct bilirubin 2 mg/dL or less and ALT less than or equal to 10 times the upper limit of normal (45 U/L)
You will not qualify if you...
- Unable to tolerate oral letermovir
- Allergy to letermovir or its components
- CMV end organ disease within 6 months before enrollment
- Prior allogeneic hematopoietic cell transplant within one year
- Planned use of other prophylactic anti-CMV medications or cellular products during the study
- Use of contraindicated medications within 14 days before Day +1 (including pimozide, ergot alkaloids, and certain drugs if receiving cyclosporine)
- Pregnant female patients
- Lactating females planning to breastfeed
- Sexually active females of reproductive potential not agreeing to effective contraception during treatment and for 4 weeks after
- Failure to provide informed consent or meet institutional, FDA, and NCI requirements for human studies
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 29 locations
1
Children's Hospital of Alabama
Birmingham, Alabama, United States, 35233
Actively Recruiting
2
UCSF Benioff Children's Hospital Oakland
Oakland, California, United States, 94609
Actively Recruiting
3
UCSF Medical Center-Mission Bay
San Francisco, California, United States, 94158
Actively Recruiting
4
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
Actively Recruiting
5
Alfred I duPont Hospital for Children
Wilmington, Delaware, United States, 19803
Actively Recruiting
6
Nemours Children's Clinic-Jacksonville
Jacksonville, Florida, United States, 32207
Actively Recruiting
7
Nicklaus Children's Hospital
Miami, Florida, United States, 33155
Actively Recruiting
8
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, United States, 96826
Actively Recruiting
9
Riley Hospital for Children
Indianapolis, Indiana, United States, 46202
Actively Recruiting
10
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, United States, 52242
Actively Recruiting
11
Norton Children's Hospital
Louisville, Kentucky, United States, 40202
Actively Recruiting
12
Children's Hospital New Orleans
New Orleans, Louisiana, United States, 70118
Actively Recruiting
13
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, United States, 21287
Actively Recruiting
14
Children's Hospital of Michigan
Detroit, Michigan, United States, 48201
Actively Recruiting
15
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
Grand Rapids, Michigan, United States, 49503
Actively Recruiting
16
Children's Mercy Hospitals and Clinics
Kansas City, Missouri, United States, 64108
Actively Recruiting
17
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
18
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
19
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
20
Saint Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
Active, Not Recruiting
21
The Children's Hospital at TriStar Centennial
Nashville, Tennessee, United States, 37203
Actively Recruiting
22
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
23
Medical City Dallas Hospital
Dallas, Texas, United States, 75230
Actively Recruiting
24
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, United States, 75390
Actively Recruiting
25
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
26
Methodist Children's Hospital of South Texas
San Antonio, Texas, United States, 78229
Actively Recruiting
27
Primary Children's Hospital
Salt Lake City, Utah, United States, 84113
Actively Recruiting
28
VCU Massey Comprehensive Cancer Center
Richmond, Virginia, United States, 23298
Not Yet Recruiting
29
University of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin, United States, 53792
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here